Biomanufacturing Associate I - Upstream

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 20850

Job Summary

The Biomanufacturing Associate I will play an integral role within CRL’s gene therapy manufacturing function by understanding and applying biological, bioprocess, manufacturing, and mechanical principles, processes, procedures, inputs, and outputs, for designated production processes and handovers, within a cGMP and GLP environment. This will ensure the timely production and release of quality products, based on client specifications. 

This role will perform a range of routine and semi-routine tasks, some of which are moderately difficult, requiring judgment in resolving issues or making recommendations, with guidance as needed, in order to proficiently execute manufacturing protocols in a regulated environment. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

•    Under guidance, apply and adhere to SOPs, cGMP, GLP, Quality, and basic Safety standards and requirements when completing tasks. o    Basic Upstream Activities (e.g., assist with solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest).  •    Follow verbal and written instructions (e.g., SOPs), when performing planned manufacturing activities, in alignment with the batch record, and under guidance.  •    With guidance, use basic quality documents and apply Good Documentation Practices. •    Ensure data integrity by accurately documenting, reviewing, and correcting work prior to submission.  •    Identify, record, and report observed process variances and deviations in real time.  •    Apply and adhere to SOPs, safety guidelines, and manufacturing instructions when completing process tasks and when operating equipment. Prepare, clean, maintain, and operate equipment and tools.  •    Recognize common safety issues and report all injuries and safety incidents immediately. •    Adhere to safe working practices and comply with site-based guidelines to avoid the consequences of error by applying:  o    Cleanroom and aseptic behaviors and procedures.  o    Proper Personal Protective Equipment (PPE) and gowning requirements.  o    Proper preparation, disinfection, sterilization, and sanitation methods and processes for equipment, etc.  o    The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials. o    Universal precautions with respect to OSHA guidelines.  o    Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.  •    Perform other responsibilities as required. 

Job Qualifications

•    Education:  High School Diploma or equivalent with high grades in science courses, or an Associates or Bachelors degree in biology/life sciences, bioengineering, or related discipline. •    Experience: 2 years of related experience with a High School Diploma. 1 year of related experience with an Associates degree. 0-1 year of related experience with a Bachelors degree. Related experience may include prior experience in a technical role and/or within a cGMP and/or biotech manufacturing environment or other related industry, etc.  •    Other: •    Able to work in accordance with the Charles River Values.  •    Able to be a team player, have a positive attitude, professional tone and demeanor, and work effectively in a collaborative environment. •    Willing and able to continuously learn and improve. •    Strong attention to detail and ability to recognize deviations from accepted practices. •    Good documentation and GDP skills. •    Must possess good analytical, critical thinking, and problem-solving skills.  •    Able to hold oneself accountable by following up and doing what they say they will do.  •    Able to complete work accurately and on time.  •    Good listening, clear written, and verbal communication skills.  •    Working knowledge of computer software (MS Word, MS Excel, Teams, database systems, etc.). 

The pay range for this position is $25.50- $28.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

Equal Employment OpportunityCharles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

Job posted: 2024-05-20

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